NCT04605627

Brief Summary

Define a signature of gut microbiota composition and related metabolites in patients with ST-elevation myocardial infarction, non ST-elevation myocardial infarction and chronic coronary disease (CAD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

September 30, 2020

Last Update Submit

October 21, 2020

Conditions

Coronary Artery DiseaseIntestinal Disease

Keywords

Gut leakageMicrobiotaCoronary artery diseaseSTEMINSTEMIChronic coronary syndrome

Outcome Measures

Primary Outcomes (8)

  • Microbiota alpha diversity in myocardial infarction measured as Chao1 Index.

    fecal-sample. 16srRNA (Miseq) will be used for sequencing.

    Within 7 days from inclusion.

  • Microbiota alpha diversity in myocardial infarction measured as Chao1 Index

    fecal-sample. 16srRNA (Miseq) will be used for sequencing.

    At 3 months follow-up.

  • Lipopolysaccharide binding protein (LBP) in myocardial infarction

    Blood sample. Analyses will be performed with ELISA.

    At inclusion

  • Lipopolysaccharide binding protein (LBP) in myocardial infarction

    Blood sample. Analyses will be performed with ELISA.

    Change from inclusion to 3 months follow-up.

  • Soluble cluster of difference-14 in myocardial infarction

    Blood sample. Analyses will be performed with ELISA.

    At inclusion

  • Soluble cluster of difference-14 in myocardial infarction

    Blood sample. Analyses will be performed with ELISA.

    Change from inclusion to 3 months follow-up.

  • Intestinal fatty acid binding protein-1 in myocardial infarction

    Blood sample. Analyses will be performed with ELISA.

    At inclusion

  • Intestinal fatty acid binding protein-1 in myocardial infarction

    Blood sample. Analyses will be performed with ELISA.

    Change from inclusion to 3 months follow-up.

Study Arms (3)

Chronic coronary syndrome

50 patients with chronic coronary disease

Non ST segment-elevation myocardial infarction

75 patients with non ST-elevation myocardial infarction

ST-elevation myocardial infarction

75 patients with ST segment-elevation myocardial infarction

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 20-75 years with coronary artery disease.

You may qualify if:

  • Coronary heart disease verified by coronary angiography

You may not qualify if:

  • Current infection requiring intravenous antibiotics
  • Inflammatory bowel disease
  • Renal failure with creatinine \> 200µmol/L
  • Hepatic impairment
  • Pregnancy
  • Previous bariatric surgery
  • Colostomy
  • Active malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Oslo University Hospital Ullevål

Oslo, N-0852, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Peripheral blood mononuclear cells (PBMC), feces

MeSH Terms

Conditions

Coronary Artery DiseaseIntestinal DiseasesST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGastrointestinal DiseasesDigestive System DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Marius Trøseid, Md Ass.prof

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geir Ø Andersen, MD.PhD

CONTACT

+4791502770g.o.andersen@medisin.uio.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Senior Cardiologist

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 28, 2020

Study Start

October 8, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Study protocol, informed consent form (in Norwegian) and clinical study report will be shared by request.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data become available 01.06.2022, and will be available until 01.06.2023.
Access Criteria
Requests by email will be answered.

Locations

NO(1)